ACRP ACRP-CP Exam Overview:
| Certification Vendor: | ACRP (Association of Clinical Research Professionals) |
|---|---|
| Exam Name: | ACRP Certified Professional (ACRP-CP) Certification Exam |
| Exam Number: | ACRP-CP |
| Exam Format: | Multiple choice, Computer-based testing |
| Exam Duration: | 180 minutes |
| Real Exam Qty: | Approximately 130 |
| Related Certifications: | ACRP Certified Clinical Research Coordinator (CCRC) ACRP Certified Clinical Research Associate (CCRA) |
| Available Languages: | English |
| Recommended Training: | ACRP Official Training & Education |
| Exam Registration: | Pearson VUE Registration Portal ACRP Certification Page |
| Sample Questions: | ACRP ACRP-CP Sample Questions |
| Exam Way: | Computer-based exam delivered via test centers and/or remote proctoring through authorized testing provider |
| Pre Condition: | Professional experience in clinical research is typically required (commonly around 2–3+ years depending on eligibility pathway); eligibility requirements vary by pathway on the official ACRP certification policy. |
| Official Syllabus URL: | https://www.acrpnet.org/ |
ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 2: Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Topic 3: Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Topic 4: Clinical Research Foundations | - Good Clinical Practice (GCP) principles - Ethical conduct in clinical trials |
| Topic 5: Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
ACRP Certified Professional Sample Questions:
Which document confirms the PI's agreement to permit auditing at the study site?
- A. IB
- B. Delegation Log
- C. Protocol
- D. ICF
Correct Answer: D 🗳️
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An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?
- A. IRB/IEC
- B. PI
- C. DSMB/IDMC
- D. Sponsor
Correct Answer: B 🗳️
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A serious unexpected ADR is one:
- A. Where the severity of the reaction is not consistent with IB.
- B. That results in the death of the subject.
- C. That does not need to be reported to the IRB/IEC.
- D. Severity and nature of the reaction is consistent with protocol.
Correct Answer: A 🗳️
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An impartial witness should be present during the entire informed consent discussion when:
- A. A legally acceptable representative is unable to read.
- B. A parent/guardian is consenting for a minor subject.
- C. A subject has been determined to be vulnerable.
- D. An interpreter is translating the consent form for a subject.
Correct Answer: A 🗳️
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A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?
- A. Re-train investigators on recruitment obligations.
- B. Evaluate the screen failures to determine if the protocol needs revision.
- C. Allocate additional monitoring resources to the trial.
- D. Reduce the target sample size based on feedback from the sites.
Correct Answer: B 🗳️
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